MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAL

Device Problems Air Leak (1008); Crack (1135); Fluid/Blood Leak (1250); Incorrect Or Inadequate Test Results (2456)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer was reported via phone call that, the customer had high and low blood glucose issues.Customer declined troubleshooting for the high blood glucose.Customer stated that, the location of the leak was in tubing.The blood glucose was over 600 mg/dl.Customer stated that, she noticed air bubbles is the tubing.Approximate size of air bubbles is unknown.Air bubbles were noticed by customer during therapy.Customer treated high blood glucose with manual injection syringe.The blood glucose was 48 mg/dl at the time of the incident and current blood glucose was unknown and today the customer noticed the tubing was cracked again blood glucose was 150 mg/dl.Customer reported the following symptoms related to their high blood glucose were nausea, vomiting.Based on customer report proceeding in troubleshooting per customer alleging possible pump under delivery.The device will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7307719
• MDR Text Key: 101316939
• Report Number: 3004209178-2018-54052
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503694
• UDI-Public: (01)00643169503694
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A4751NALJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 160